Senior Aseptic Quality Assurance Officer | Walsall Healthcare NHS Trust

The Band 7 Quality Assurance (QA) Officer plays a key role in ensuring the safe, compliant, and effective delivery of aseptic services within Pharmacy. The post holder is responsible for overseeing and managing Good Manufacturing Practice (GMP) activities, ensuring adherence to all relevant legislation, national guidance, and local policies. They will lead the implementation, development, and ongoing maintenance of the Pharmaceutical Quality System (PQS), monitoring its effectiveness across aseptic and cancer services. The role provides expert QA input into the review of aseptic products and processes, supporting continuous quality improvement and maintaining high standards of patient safety. The post holder will act as a senior QA Officer, supporting the delivery of a safe, efficient, and legally compliant aseptic service.

Main Duties Overview

• Lead and maintain the Pharmaceutical Quality System (PQS), ensuring compliance with GMP, legislation, and national guidance, and driving continuous quality improvement.
• Oversee investigations, root cause analysis (RCA), CAPA implementation, change control, deviations, complaints, recalls, validation, and quality trend reporting.
• Develop and manage the Quality Management Systems (QMS) and contribute to performance monitoring through KPIs.
• Provide expert QA advice to Aseptic Services, supporting high standards in product quality, process compliance, and patient safety.
• Lead and support deviation management processes, ensuring timely investigation, resolution, and effectiveness of corrective actions.
• Support environmental monitoring programmes, data analysis, trend identification, and implementation of improvement plans.
• Contribute to validation activities (URS, DQ, IQ, OQ, PQ), Validation Master Plans, and ongoing equipment and process qualification.
• Ensure compliance of materials, products, and specifications with GxP standards, including stability assessment and supplier agreements (SLAs/TAs).
• Support audits, self-inspections, and governance activities, and deliver QA/GxP training to staff.
• Provide leadership, supervision, and line management, including staff development, recruitment, and performance management.
• Undertake ACT (accuracy checking and approval of pre-filled chemotherapy).
• Contribute to operational service delivery, including aseptic preparation, dispensing, and cross-functional duties as needed.
• Support safe use of medicines, risk management (including COSHH), and continuous improvement in patient care.
• Act as an authorised signatory for relevant financial and HR processes.

What do we offer

This role offers excellent opportunities for professional growth and development. You will be supported to expand your expertise in quality assurance and aseptic services, with potential opportunities for further progression. Where appropriate and subject to service needs and individual performance, there may be the opportunity to be supported to develop towards and apply for postgraduate courses such as the PTQA in the future. We are looking for motivated, forward-thinking individuals who are keen to make a difference, drive quality improvement, and contribute to a patient-centred service. In return, you will join a collaborative organisation that values its staff, supports career progression, and encourages continuous learning.